FDA Registration
Active
🇺🇸 United States
LSISol6612(PL) - SEW EASY Combo Kit
Reg #: 2032112
·
FEI: 3003076831
·
Expires 2025
Products
1
Proprietary Names
17
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Isomedix Operations Inc.
- Registration Number
- 2032112
- FEI Number
- 3003076831
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7685 ST.ANDREWS AVE.
- City
- SAN DIEGO
- State
- CA
- ZIP
- 92154
- Country
- US
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 9072619
- Address
- 5960 Heisley Road, --
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2012-12-27 |
Proprietary Names
LSISol6612(PL) - SEW EASY Combo Kit
LSISol6612 (PL) - SEW-EASY Device Kit
LSISol6612(PL) - RAM RING
LSISol6612 (PL) - SEW-EASY Cassettes
LSISol6612 (PL) - MINI-RUMEL
LSISol6612 (PL) - SEW-EASY Device Kit, 5mm
LSISol6612 (PL) - RAM PACK
LSISol6612 (PL) - SEW-EASY SNARE
LSISol6612 (PL) - Aortic Root Retractor, Medium
LSISol6612 (PL) - 3D MINI ACESS PORTAL
LSISol6612(PL) - RAM Device 5mm
LSISol6612 (PL) - SEW-EASY COMBO Kit, 5mm
LSISol6612 (PL) - Aortic Root Retractor, Small
LSISol6612 (PL) - RAM Device
LSISol6612 (PL) - SEW-EASY Cassette Singles, 5mm
LSISol6612 (PL) - SEW-EASY M Device
LSISol6612 (PL) - Aortic Root Retractor, Large
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)